9 In-Depth ISO 10993-19 Questions for Professionals

What is involved in ISO 10993-19

Find out what the related areas are that ISO 10993-19 connects with, associates with, correlates with or affects, and which require thought, deliberation, analysis, review and discussion. This unique checklist stands out in a sense that it is not per-se designed to give answers, but to engage the reader and lay out a ISO 10993-19 thinking-frame.

How far is your company on its ISO 10993-19 journey?

Take this short survey to gauge your organization’s progress toward ISO 10993-19 leadership. Learn your strongest and weakest areas, and what you can do now to create a strategy that delivers results.

To address the criteria in this checklist for your organization, extensive selected resources are provided for sources of further research and information.

Start the Checklist

Below you will find a quick checklist designed to help you think about which ISO 10993-19 related domains to cover and 9 essential critical questions to check off in that domain.

The following domains are covered:

ISO 10993-19, ISO 10993, Biocompatibility, Medical devices:

ISO 10993-19 Critical Criteria:

Unify ISO 10993-19 goals and clarify ways to gain access to competitive ISO 10993-19 services.

– What are your key performance measures or indicators and in-process measures for the control and improvement of your ISO 10993-19 processes?

– To what extent does management recognize ISO 10993-19 as a tool to increase the results?

– What is Effective ISO 10993-19?

ISO 10993 Critical Criteria:

Refer to ISO 10993 failures and triple focus on important concepts of ISO 10993 relationship management.

– What role does communication play in the success or failure of a ISO 10993-19 project?

– Does our organization need more ISO 10993-19 education?

– Does ISO 10993-19 appropriately measure and monitor risk?

Biocompatibility Critical Criteria:

Analyze Biocompatibility quality and budget the knowledge transfer for any interested in Biocompatibility.

– What are the key elements of your ISO 10993-19 performance improvement system, including your evaluation, organizational learning, and innovation processes?

– Who needs to know about ISO 10993-19 ?

Medical devices Critical Criteria:

Accumulate Medical devices outcomes and optimize Medical devices leadership as a key to advancement.

– What are the Essentials of Internal ISO 10993-19 Management?


This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the ISO 10993-19 Self Assessment:


Author: Gerard Blokdijk

CEO at The Art of Service | http://theartofservice.com



Gerard is the CEO at The Art of Service. He has been providing information technology insights, talks, tools and products to organizations in a wide range of industries for over 25 years. Gerard is a widely recognized and respected information expert. Gerard founded The Art of Service consulting business in 2000. Gerard has authored numerous published books to date.

External links:

To address the criteria in this checklist, these selected resources are provided for sources of further research and information:

ISO 10993 External links:

A Practical Guide to ISO 10993-10: Irritation | MDDI Online

A Practical Guide to ISO 10993-10: Sensitization | MDDI …

Biocompatibility Testing & ISO 10993 Tests – Pacific Biolabs

Biocompatibility External links:

Contact Lens Biocompatibility Analysis – LSU Eye Center

Biocompatibility Testing Services | NAMSA

Medical devices External links:

Project and Risk Management for medical devices | Gantus …

Altair Instruments | Medical Devices | Aesthetic Machines